Table 1.
Design summary for independent variables.
Table 2.
Proposed formulation compositions for herbal capsule.
Table 3.
Actual and coded design constraints for the herbal capsule formulation.
Fig 1.
Extract-extract compatibility profile.
The black, purple, and blue chromatograms represent chemical fingerprints for AEFE, MCFE, and their binary mixture (1:1). A well-resolved peak was found at approximately 8.5 minutes in all the preparations. Conditions: mobile phase: 0.01% trifluoroacetic acid water: methanol: acetonitrile (30:60:10 v/v); Column C18; Detection: 210 nm.
Table 4.
Effect of varied dose ratio on fasting plasma glucose levels in rats.
Table 5.
Technological properties of proposed herbal capsule formulations.
Table 6.
The compositions and quality attributes of herbal capsule formulation.
Fig 2.
The contour diagram (P) and the 3D diagram (Q) represent three-component systems. It shows the relationships between the levels of the independent variables (magnesium carbonate (A), magnesium stearate (B), and talc (C) at a fixed level of sodium bicarbonate (G) of 20 mg, Sodium benzoate (D) of 0.6 mg, and 76% of active pharmaceutical ingredients (E = MCFE and F = AEFE) on flowability as measured by Hausner’s ratio (HR). Each tip of the triangle indicates each independent variable’s maximum level, whereas the three lines (AB, BC, CA) represent a binary mixture with the third variable kept on a fixed level in the center of the line. The blue-colored space indicates the combinations where the best desirable flowability can be achieved. The decrease in the amount of A and B increases flowability (low HR), with further decrease, leading to a decrease in flowability (high HR).
Table 7.
ANOVA for a quadratic model for flowability.
Fig 3.
Overlay plot for optimal levels of excipients in a capsule formulation.
The overlay plot illustrates the design space of the effects of magnesium carbonate (A = X1), magnesium stearate (B = X2), talc (C = X3) at a fixed level of sodium bicarbonate (G) of 12.3613, and 76% of active pharmaceutical ingredients (MCFE and AEFE) on flowability measured by Hausner’s ratio. The yellow areas (design space) indicate the region where excellent flowability can be obtained.
Table 8.
Results of confirmation experiments.
Fig 4.
Herbal granules (A) and the DM083 capsules (B). (a) Herbal granules contain 76% of dried herbal extracts as active pharmaceutical ingredients mixed with excipients. (b) Herbal capsules in a plastic airtight container; were produced using a manual capsule filling machine [Lodha, LI-CFM 300, India]. The capsules have a size of 00 and contain 600 mg of herbal granules.